GBS PNA FISH— 510(k) K082612

Substantially Equivalent

Advandx, Inc.

FDA 510(k) clearance K082612 for GBS PNA FISH, Substantially Equivalent on 2009-05-05. Applicant: Advandx, Inc..

Clearance details

Applicant: Advandx, Inc.
Product code: Code OAH
Advisory panel: Microbiology
Date received: 2008-09-09
Decision date: 2009-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

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